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NCT Number: NCT07600151

Etenta-Isa-VRd in Newly Diagnosed High-Risk Multiple Myeloma

This study is researching an experimental five-drug combination called etentamig, isatuximab, bortezomib, lenalidomide, and dexamethasone. The study is focused on participants with newly diagnosed multiple myeloma (NDMM) and high-risk disease who are eligible for autologous stem cell transplantation.

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Key information

Conditions

Myeloma Multiple Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have confirmed diagnosis of symptomatic MM per IMWG criteria.
  • Participants must have High-risk myeloma according to IMS/IMWG CGS
  • Participants must be considered a candidate for high-dose chemotherapy and ASCT, as described in the protocol.
  • Participants must have measurable disease as defined in the protocol. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (WHO=3 is allowed only if caused by MM and not by co-morbid conditions).
  • Participants must have clinical laboratory values within a prespecified range.

Exclusion criteria

  • Known contraindications to the use of any IMP or axMP or required concomitant drugs or supportive treatment.
  • known systemic amyloidosis (except for AL amyloidosis of the skin or the bone marrow), POEMS syndrome, Waldenstrom's macroglobulinemia; primary plasma cell leukemia
  • Administration of systemic therapy for multiple myeloma except osteoprotective therapy. Emergency myeloma treatment with dexamethasone is allowed according to specifications in the protocol. It is allowed to include patients after 1 cycle of any anti-myeloma first-line treatment within the specifications of the protocol
  • known central nervous system involvement by MM.

Treatment and study plan

Etentamig

Drug

Administered per the protocol

Isatuximab

Drug

Administered per the protocol

Bortezomib + Lenalidomide + Dexamethasone

Drug

Administered per the protocol

Primary outcomes

  1. Safety and tolerability (Phase I)

    Time frame: through induction treatment, on average 4 months

    Number of dose-limiting toxicities (DLTs) in participants and rates of adverse events (AEs) of grade ≥2 and of severe AEs in participants

  2. MRD negativity (Phase II)

    Time frame: through consolidation phase completion, an average of 1 year

    MRD-negativity rate after 12 cycles (with a sensitivity of <10-5)

  3. PFS

    Time frame: up to 10 years

    Progression-free survival

Secondary outcomes

  1. ORR

    Time frame: up to 10 years

    Overall response rate

  2. CR rate

    Time frame: up to 10 years

    Complete Response Rate

  3. VGPR Rate

    Time frame: up to 10 years

    Very good partial response rate

  4. DoR

    Time frame: up to 10 years

    Duration of Response

  5. TTR

    Time frame: up to 10 years

    Time to response

  6. PFS2

    Time frame: up to 10 years

    Progression free survival 2

  7. OS

    Time frame: up to 10 years

    Overall survival

  8. MRD negativity

    Time frame: up to 10 years

    Minimal Residual Disease (MRD) Negativity Rate (10-5 to 10-6)

  9. Sustained MRD

    Time frame: up to 10 years

    Sustained MRD negativity rate (for a duration of 6-months, and multiples therof)

  10. MRD-negative CR

    Time frame: up to 10 years

    Rates of MRD-negative Complete Responses

  11. Sustained MRD-negative CR

    Time frame: up to 10 years

    Rate of Sustained MRD-negative Complete Response

Study contacts

Contact information is provided by the study sponsor or research team.

Katja Weisel

CONTACT

[email protected]

+4940-7410-0

Lisa Leypoldt

CONTACT

[email protected]

+4940-7410-0

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • AbbVie
  • Sanofi

Registry information

Official study title

A Clinical Phase I/II, Multicenter, Open-label, National Study Evaluating Quintuplet Treat-ment With ISaTuximab, Bortezomib, Lenalidomide and Dexamethasone Plus Etentamig (Etenta-Isa-VRd) in Primary DiagnOsed High-Risk Multiple Myeloma Patients

Acronym: CONQUISTADOR

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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